Repair device and method for deploying anchors

ABSTRACT

A bone or tissue repair device can deploy first and second anchors from a distal end of a bore of a needle. A cylindrical first anchor can be disposed in the bore proximal to a distal end of the bore. A cylindrical second anchor can be disposed in the bore proximal to the first anchor. A pusher wire can include teeth positioned at a distal end of the pusher wire. The pusher wire and teeth can be configured to engage an interior of the first anchor; advance distally, with respect to the needle, to force the first anchor distally out of the bore; retract proximally, with respect to the needle and the second anchor, to position the teeth inside an interior of the second anchor; engage the interior of the second anchor; and advance distally, with respect to the needle, to force the second anchor distally out of the bore.

CLAIM OF PRIORITY

This application is a continuation of U.S. patent application Ser. No.15/482,106, filed on Apr. 7, 2017, which claims the benefit of priorityto U.S. Provisional Application Ser. No. 62/320,860, filed on Apr. 11,2016, each of which is incorporated herein by reference in its entirety.

FIELD OF THE DISCLOSURE

The present disclosure relates to deploying anchors for bone or tissuerepair surgery.

BACKGROUND OF THE DISCLOSURE

In the human body, bone or tissue can require repair. For example, ameniscus is a fibrocartilaginous structure found within a joint, such asa knee joint. Forceful twisting or rotation of the knee (or other joint)can tear the meniscus, which can require surgical repair of themeniscus.

SUMMARY

In a first embodiment, a bone or tissue repair device can deploy firstand second anchors from a distal end of a bore of a needle. Acylindrical first anchor can be sized and shaped to be disposed in thebore proximal to a distal end of the bore. A cylindrical second anchorcan be sized and shaped to be disposed in the bore proximal to the firstanchor. A pusher wire can include teeth positioned at a distal end ofthe pusher wire. The teeth can be configured to engage an interior ofthe first anchor; advance distally, with respect to the needle, to forcethe first anchor distally out of the bore; retract proximally, withrespect to the needle and the second anchor, to position the teethinside an interior of the second anchor; engage the interior of thesecond anchor; and advance distally, with respect to the needle, toforce the second anchor distally out of the bore.

In a second embodiment, a method for deploying first and second anchorsfrom a distal end of a bore of a needle can include engaging an interiorof the first anchor with teeth, the teeth being positioned at a distalend of a pusher wire. The method can further include advancing thepusher wire distally, with respect to the needle, to force the firstanchor distally out of the bore. The method can further includeretracting the pusher wire proximally, with respect to the needle andthe second anchor, to position the teeth inside an interior of thesecond anchor. The method can further include engaging the interior ofthe second anchor with the teeth. The method can further includeadvancing the pusher wire distally, with respect to the needle, to forcethe second anchor distally out of the bore.

In a third embodiment, a bone or tissue repair device can include aneedle defining a bore extending through a distal end of the needle. Acylindrical first anchor can be disposed in the bore proximal to adistal end of the bore. A cylindrical second anchor can be disposed inthe bore proximal to the first anchor and connected to the cylindricalfirst anchor by an adjustable suture loop. A pusher wire can have anouter diameter smaller than respective inner diameters of the first andsecond anchors, so that the pusher wire is non-engagingly slidablethrough the first and second anchors in the proximal and distaldirections. The pusher wire can include teeth positioned at a distal endof the pusher wire. The teeth can being sized and shaped to: catch andengage on interiors of the first and second anchors when the pusher wireand teeth are advanced distally with respect to the first and secondanchors, respectively; and slide along the interiors of the first andsecond anchors non-damagingly when the pusher wire and teeth areretracted proximally with respect to the first and second anchors,respectively. A tube pusher can be positioned over the pusher wirewithin the bore of the needle. The tube pusher can have a distal portionthat extends radially beyond an outer circumference of the secondanchor, so that the tube pusher pushes the second anchor distally as thetube pusher advances distally within the bore of the needle. A handlecan be fixedly coupled to a proximal end of the needle. A push buttoncan be disposed on an exterior of the handle, the push button beingslidable proximally and distally with respect to the handle between afirst proximal position and a first distal position. The push button canbe coupled to the pusher wire so that proximal and distal movement ofthe push button produces proximal and distal movement of the pusher wireand teeth.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a cross-sectional view of a distal portion of an example ofa repair device prior to use, in accordance with some embodiments.

FIGS. 2A-D show cross-sectional views of a first example of a deploymentscheme for a repair device, in four sequential stages of use, inaccordance with some embodiments.

FIGS. 3A-D show cross-sectional views of a second example of adeployment scheme for a repair device, in four sequential stages of use,in accordance with some embodiments.

FIGS. 4A-D show cross-sectional views of a third example of a deploymentscheme for a repair device, in four sequential stages of use, inaccordance with some embodiments.

FIG. 5A shows a perspective view of an example of a repair device priorto use, in accordance with some embodiments. FIG. 5B shows a cutawayview of the distal portion of the repair device of FIG. 5A, inaccordance with some embodiments.

FIG. 6A shows a perspective view of the example of the repair device ofFIG. 5A, after the first anchor has been deployed, in accordance withsome embodiments. FIG. 6B shows a cutaway view of the distal portion ofthe repair device of FIG. 6A, in accordance with some embodiments.

FIG. 7A shows a perspective view of the example of the repair device ofFIGS. 5-6, after the first anchor has been deployed, and after the pushbutton has been retracted proximally to its original location, inaccordance with some embodiments. FIG. 7B shows a cutaway view of thedistal portion of the repair device of FIG. 7A, in accordance with someembodiments.

FIG. 8A shows a perspective view of the example of the repair device ofFIGS. 5-7, as the second anchor is being deployed, in accordance withsome embodiments. FIG. 8B shows a cutaway view of the distal portion ofthe repair device of FIG. 8A, in accordance with some embodiments.

FIG. 9 shows a side view of an example of a repair device, including thesuture loop and single strand of suture, in accordance with someembodiments.

FIG. 10 shows a close-up side cross-sectional view of a distal end ofthe repair device of FIG. 9, including the suture loop and single strandof suture, in accordance with some embodiments.

FIG. 11 shows an exploded view of the repair device of FIG. 9, inaccordance with some embodiments.

FIG. 12 shows a flow chart of an example of a method for deploying firstand second anchors from a distal end of a bore of a needle, inaccordance with some embodiments.

FIGS. 13-29 show views of various stages of a specific example of how asurgeon can use a meniscal repair device.

Corresponding reference characters indicate corresponding partsthroughout the several views. Elements in the drawings are notnecessarily drawn to scale. The configurations shown in the drawings aremerely examples, and should not be construed as limiting the scope ofthe invention in any manner.

DETAILED DESCRIPTION

To repair a bone or tissue structure in the human body, such as a tearin the meniscus, a surgeon can deploy two soft anchors connected by aloop of suture. The surgeon can use a repair device to pierce the tissueon one side of the tear, deploy an anchor, pull the repair device backthrough the tissue, pierce the tissue on the other side of the tear, anddeploy a second anchor. The surgeon can pull on the suture to draw thetwo deployed anchors together, which can close the tear. The surgeon canthen cut the suture.

There is ongoing effort to improve the repair devices, such as makingthe devices smaller, easier to use, and less prone to damage surroundingtissue during a repair procedure.

FIG. 1 shows a cross-sectional view of a distal portion of an example ofa repair device 100 prior to use, in accordance with some embodiments.FIGS. 5-11, discussed below, show the full device. The configuration ofFIG. 1 is but one example of a repair device 100; other configurationscan also be used.

A needle 102 can define a bore 104 extending through a distal end 106 ofthe needle 102. In some of the specific examples presented below, theneedle 102 has a curved distal portion. In other examples, the needle102 can have a straight distal portion. In some examples, the needle 102can have an angled distal end 106; in other examples, the needle 102 canhave a straight distal end 106 (e.g., perpendicular to a longitudinalaxis of the needle 102).

A cylindrical first anchor 108 can be disposed in the bore 104 proximalto a distal end 110 of the bore 104. A cylindrical second anchor 112 canbe disposed in the bore 104 proximal to the first anchor 108. In someexamples, the first 108 and second 112 anchors are placed into the boreduring assembly of the repair device 100, so that the repair device 100can be sold or purchased in an assembled state, prior to use. In otherexamples, the first 108 and second 112 anchors can be packagedseparately, and can be inserted into the repair device 100 prior to use.

In some examples, the first 108 and second 112 anchors can be made froma relatively soft material, and can bend and deform under the force of asuture or other elements on the repair device 100. In some examples, thefirst 108 and second 112 anchors can be nominally shaped as cylinders,or tubes having a circular or elongated cross-section, but can bedeformed during assembly into the repair device 100 and/or duringdeployment. In some examples, the term cylindrical is intended tosignify that the anchor has a cross-section that is invariant from onelongitudinal end of the anchor to the opposite longitudinal end of theanchor. In these examples, the anchors can have a hollow interior. Insome examples, the first 108 and second 112 anchors can be connected byan adjustable suture loop (shown in FIG. 10).

A pusher wire 114 can have an outer diameter smaller than respectiveinner diameters of the first 108 and second 112 anchors, so that thepusher wire 114 is non-engagingly slidable through the first 108 andsecond 112 anchors in the proximal and distal directions. The pusherwire 114 can be capable of transmitting a pushing force in the distaldirection and a pulling force in the proximal direction. The pusher wire114 can be actuated from a proximal portion of the pusher wire 114(shown in FIGS. 5-9 and 11).

The pusher wire 114 can include teeth 116 positioned at a distal end 118of the pusher wire 114. In some examples, the teeth 116 can be sized andshaped to catch and engage on interiors of the first and second anchorswhen the pusher wire and teeth are advanced distally with respect to thefirst and second anchors, respectively. In some examples, the teeth 116can be sized and shaped to slide along the interiors of the first andsecond anchors non-damagingly when the pusher wire and teeth areretracted proximally with respect to the first and second anchors,respectively.

The pusher wire 114 and teeth 116 can be configured to engage aninterior 120 of the first anchor 108. The pusher wire 114 and teeth 116can be further configured to advance distally, with respect to theneedle 102, to force the first anchor 108 distally out of the bore 104.The pusher wire 114 and teeth 116 can be further configured to retractproximally, with respect to the needle 102 and the second anchor 112, toposition the teeth 116 inside an interior 122 of the second anchor 112.The pusher wire 114 and teeth 116 can be further configured to engagethe interior 122 of the second anchor 112. The pusher wire 114 and teeth116 can be further configured to advance distally, with respect to theneedle 102, to force the second anchor 112 distally out of the bore 104.

A tube pusher 124 can be positioned over the pusher wire 114 within thebore 104 of the needle 102. The tube pusher 124 can have a distalportion that extends radially beyond an outer circumference of thesecond anchor 112, so that the tube pusher 124 can push the secondanchor 112 distally as the tube pusher 124 advances distally within thebore 104 of the needle 102. The tube pusher 124 can be actuated from aproximal portion of the tube pusher 124 (shown in FIGS. 5-9 and 11).

To actuate the pusher wire 114 and the tube pusher 124, a surgeon canslide a push button on a handle fixedly coupled to a proximal end of theneedle 102. The push button can be slidable proximally and distally withrespect to the handle between a first proximal position and a firstdistal position. The push button can be coupled to the pusher wire 114so that proximal and distal movement of the push button producesproximal and distal movement of the pusher wire 114 and teeth 116. FIGS.5-9 and 11 below show a detailed example of a handle, a push button, andthe mechanism used to couple motion of the push button to motion of thepusher wire 114 and tube pusher 124.

FIG. 1 shows the repair device 100 in a fully assembled state, prior touse. In this assembled state, the first anchor 108 is positioned in thebore 104, the second anchor 112 is positioned in the bore 104 proximalto the first anchor 108, the pusher wire 114 extends distally throughthe second anchor 112 to the first anchor 108, the teeth 116 on thedistal end 118 of the pusher wire 114 are positioned inside the firstanchor 108, and the tube pusher 124 is positioned over the pusher wire114 and proximal to the second anchor 112.

During use, there are several schemes for which the pusher wire 114 andteeth 116, and the tube pusher 124, can deploy the first 108 and second112 anchors. These schemes can include different motions, differentstopping points on ranges of travel, and/or different pairings ofmotions for the pusher wire/teeth and tube pusher. FIGS. 2-4 show threeexamples of deployment schemes for the repair device 100 of FIG. 1. Itwill be understood that these are merely examples, and that otherdeployment schemes can also be used. In each of these deploymentschemes, a handle of the repair device 100 and its associated mechanicalcomponents can actuate the pusher wire 114 and tube pusher 124 in amanner suitable to produce the corresponding deployment scheme.

FIGS. 2A-D show cross-sectional views of a first example of a deploymentscheme for a repair device 200, in four sequential stages of use, inaccordance with some embodiments.

In FIG. 2A, the repair device 200 is shown in an assembled state, priorto use. In some examples, in the assembled state, prior to use, a pushbutton on a handle is positioned at a first proximal position.

During use, in a first motion, a surgeon slides the push button distallyto a first distal position on the handle, which can be a distal end of arange of travel for the push button. The handle can emit an audibleclick when the push button reaches the first distal position on thehandle. FIG. 2B shows the repair device 200 after this first motion. Inthe deployment scheme of FIGS. 2A-D, the first motion advances thepusher wire 114 distally, to deploy the first anchor 108. In thedeployment scheme of FIGS. 2A-D, the first motion also advances the tubepusher 124 distally, to distally advance the second anchor 112 to occupyapproximately the same location held by the first anchor 108 prior touse (FIG. 2A).

During use, in a second motion, the surgeon slides the push buttonproximally, to a first proximal position on the handle, which can be aproximal end of a range of travel for the push button. The handle canemit an audible click when the push button reaches the first proximalposition on the handle. FIG. 2C shows the repair device 200 after thissecond motion. In the deployment scheme of FIGS. 2A-D, the second motionretracts the pusher wire 114 proximally, to position the teeth 116inside the second anchor 112. In the example of FIGS. 2A-D, the secondmotion positions the teeth 116 at the same position held by the teeth116 prior to use (FIG. 2A). In the deployment scheme of FIGS. 2A-D, thesecond motion does not reposition the tube pusher 124 (e.g., does notmove the tube pusher 124 proximally).

During use, in a third motion, the surgeon slides the push buttondistally back to the first distal position on the handle, which can be adistal end of a range of travel for the push button. The handle can emitanother audible click when the push button again reaches the firstdistal position on the handle. FIG. 2D shows the repair device 200 afterthis third motion. In the deployment scheme of FIGS. 2A-D, the thirdmotion advances the pusher wire 114 distally, to deploy the secondanchor 112. In the deployment scheme of FIGS. 2A-D, the third motionalso advances the tube pusher 124 distally, to follow the distal motionof the pusher wire 114.

FIGS. 3A-D show cross-sectional views of a second example of adeployment scheme for a repair device 300, in four sequential stages ofuse, in accordance with some embodiments.

The assembled state (FIG. 3A), the state after the first motion (FIG.3B), and the state after the second motion (FIG. 3C) are the same as thecorresponding states shown in FIGS. 2A-C.

The third motion differs from the deployment scheme of FIG. 2A-D, inthat the third motion advances the pusher wire 114 distally, to deploythe second anchor 112, but does not advance the tube pusher 124distally. In the state after the third motion (FIG. 3D), the tube pusher124 remains at the same location as after the second motion (FIG. 3C).

FIGS. 4A-D show cross-sectional views of a third example of a deploymentscheme for a repair device 400, in four sequential stages of use, inaccordance with some embodiments.

The assembled state (FIG. 4A) is the same as the corresponding stateshown in FIG. 3A.

The first motion differs from the deployment scheme of FIG. 3A-D, inthat the first motion advances the pusher wire 114 distally, to deploythe first anchor 108, but does not advance the tube pusher 124 distally.In the state after the first motion (FIG. 4B), the tube pusher 124 ispositioned at the same location as in the assembled state (FIG. 4A),which is proximal to where the tube pusher 124 is located in the exampleof FIG. 3B.

The second motion differs from the deployment scheme of FIG. 3A-D, inthat the second motion retracts the pusher wire 114 farther than theassembled state (FIG. 4A), to position the teeth 116 inside the secondanchor 112. In the state after the second motion (FIG. 4C), the teeth116 are positioned proximal to the corresponding position in theassembled state (FIG. 4A).

The third motion advances the pusher wire 114 distally, but does notmove the tube pusher 124. Note that in the configuration of FIGS. 4A-D,a push button 3 (FIG. 5) and a handle 5 (FIG. 5) can be configured suchthat a proximal or distal motion of the push button 3 on the handle 5does not move the tube pusher 124 proximally or distally.

The anchor deployment schemes of FIGS. 2-4 are but three examples. Othersuitable anchor deployment schemes can also be used. FIGS. 5-11 show anexample of a full device that uses the first deployment scheme (FIGS.2A-D). It will be understood that one of ordinary skill in the art canmodify the elements of the full device to use the second deploymentscheme (FIGS. 3A-D), the third deployment scheme (FIGS. 4A-D), or anyother suitable deployment scheme.

FIG. 5A shows a perspective view of an example of the repair device 100prior to use, in accordance with some embodiments. FIG. 5B shows acutaway view of the distal portion of the repair device 100 of FIG. 5A,in accordance with some embodiments.

The device of FIGS. 5A and 5B can include the elements shown in FIG. 1,but with additional elements and a more realistic package design.Although many of the elements in FIGS. 5A and 5B are present in FIG. 1,it is instructive to discuss them in the context of the augmented deviceshown in FIGS. 5A and 5B.

The repair device 100 includes a needle 102 at its distal end. Theneedle 102 can be shaped as a cylindrical tube, with a tip sharp enoughto pierce tissue. In some examples, the tip is angled. The needle 102can define a bore therethrough. In some examples, the needle 102 andbore are shaped so that when a surgeon advances the needle 102 throughtissue, the needle pierces the tissue without clogging the bore. Therepair device 100 can store the anchors and anchor deployment mechanismin the bore of the needle 102.

A first anchor 108 can be positioned in the bore of the needle 102 andproximal to the tip of the needle 102. The first anchor 108 can beshaped as a cylinder, so that the first anchor 108 can slide overadditional elements during assembly of the repair device 100, and sothat a deployment mechanism can grip the first anchor 108 from aninterior of the first anchor 108.

The deployment mechanism includes a pusher wire 114, and teeth 116positioned on a distal end of the pusher wire 114. In some example, adistal portion of the pusher wire 114 can be laser-cut to impartadditional flexibility to the pusher wire 114, so that the pusher wire114 can more easily navigate a curved distal end of the needle 102. Theteeth 116 are angled to catch and engage on the interior of the firstanchor 108 when the pusher wire 114 and teeth 116 are advanced distallywith respect to the first anchor 108, but slide along the interior ofthe first anchor 108 non-damagingly when the pusher wire 114 and teeth116 are retracted proximally with respect to the first anchor 108. Therepair device 100 can be assembled such that the first anchor 108 can beslid distally over the pusher wire 114 and teeth 116, or, equivalently,the pusher wire 114 and teeth 116 can be retracted proximally throughthe interior of the first anchor 108.

During use of the repair device 100, the surgeon pierces tissue with theneedle 102, guides the needle 102 to a suitable location andorientation, then deploys the first anchor 108. To deploy the firstanchor 108, the surgeon distally advances push button 3 with respect toa handle 5. The push button 3 is coupled to a distal end or a distalportion of a tube pusher assembly 6 (which includes the pusher wire 114and teeth 116), and the distal motion of the push button 3 forces thetube pusher assembly 6 in a distal direction. The teeth 116 engage theinterior of the first anchor 108, and push the first anchor 108 out ofthe bore of the needle 102 and distally past the distal end of theneedle 102.

FIG. 6A shows a perspective view of the example of the repair device 100of FIG. 5A, after the first anchor has been deployed, in accordance withsome embodiments. FIG. 6B shows a cutaway view of the distal portion ofthe repair device 100 of FIG. 6A, in accordance with some embodiments.

Compared with the views of FIGS. 5A and 5B, in FIGS. 6A and 6B, the pushbutton 3 has been advanced distally, the tube pusher assembly 6(including the pusher wire 114 and teeth 116) has been advanceddistally, the first anchor has been forced distally out of the bore ofthe needle 102 and has been deployed at a suitable location in the boneor tissue, and the tube pusher assembly 6 has forced the second anchor112 distally within the bore of the needle 102. In some examples, thetube pusher assembly 6 includes a portion 602 extending laterally beyonda diameter of the second anchor 112, so that when the tube pusherassembly 6 is forced distally, the portion 602 forces the second anchor112 distally.

In some examples, the repair device 100 can emit an audible click whenthe push button 3 is fully advanced distally. The click is produced byat least one outward-biased tab on the tube pusher assembly 6 snappinginto a corresponding inward-facing step on the handle 5 or on an elementattached to the handle 5. By snapping into the step, the outward-biasedtab also blocks the tube pusher assembly 6 from moving proximally beyondthe location at which the snapping occurs, with respect to the handle 5,but still allows the tube pusher assembly 6 to move distally, withrespect to the handle 5.

FIG. 7A shows a perspective view of the example of the repair device 100of FIGS. 5-6, after the first anchor has been deployed, and after thepush button 3 has been retracted proximally to its original location, inaccordance with some embodiments. FIG. 7B shows a cutaway view of thedistal portion of the repair device 100 of FIG. 7A, in accordance withsome embodiments.

When the push button 3 is retracted proximally, the tube pusher assembly6 is also retracted proximally while the second anchor 112 remainsstationary. The proximal retraction places the teeth 116 within theinterior of the second anchor 112, so that a subsequent distal movementof the pusher wire 114 and teeth 116 can engage the interior of thesecond anchor 112 and push the second anchor 112 out of the bore of theneedle 102, thereby deploying the second anchor 112 at a suitablelocation in the bone or tissue.

FIG. 7A reveals several of the outward-biased tabs 702 on the tubepusher assembly 6, which snap into corresponding steps on a front endreversed curve sub assembly 7 (FIG. 11) that is attached to the handle5. These tabs 702 emit the audible click that alerts the surgeon thatthe push button 3 is fully advanced distally (as in FIGS. 6A and 6B).These tabs 702, when snapped into the corresponding steps, are coupledto the second anchor 112 and therefore hold the second anchor 112 at thesame location, with respect to the handle 5, when the push button 3 andtube pusher assembly 6 are retracted proximally (as in FIGS. 7A and 7B).

FIG. 8A shows a perspective view of the example of the repair device 100of FIGS. 5-7, as the second anchor is being deployed, in accordance withsome embodiments. FIG. 8B shows a cutaway view of the distal portion ofthe repair device 100 of FIG. 8A, in accordance with some embodiments.

Compared with the views of FIGS. 7A and 7B, in FIGS. 8A and 8B, the pushbutton 3 has been advanced distally a second time, the tube pusherassembly 6 (including the pusher wire 114 and teeth 116) has beenadvanced distally a second time, and the second anchor has been forceddistally out of the bore of the needle 102 and has been deployed at asuitable location in the bone or tissue.

In some examples, the repair device 100 can emit a second audible clickwhen the push button 3 is fully advanced distally. The click is producedby the outward-biased tabs 702 snapping into another set ofcorresponding inward-facing steps on the handle 5 or on an elementattached to the handle 5, such as the front end reversed curve subassembly 7 (FIG. 11).

Once the second anchor is deployed, the surgeon can withdraw the repairdevice 100 proximally from the second anchor.

FIG. 9 shows a side view of an example of a repair device 100, includingthe suture loop 902 and single strand 904 of suture, in accordance withsome embodiments. During the advancing and retracting of the push button3, as in FIGS. 5-8, the surgeon can take care to ensure that the sutureloop 902 and suture strand 904 are not tangled and can be accessed afterthe anchors have been deployed.

FIG. 10 shows a close-up side cross-sectional view of a distal end ofthe repair device 100 of FIG. 9, including the suture loop 902 andsingle strand 904 of suture, in accordance with some embodiments.

FIG. 11 shows an exploded view of the repair device 100 of FIG. 9, inaccordance with some embodiments. The configuration of elements in FIG.1 is but one example; other suitable configurations can also be used.

During assembly of the repair device 100, first and second anchors (notshown) can be loaded onto a proximal end of a pusher wire subassembly 2,and advanced distally along the a pusher wire subassembly 2. The pusherwire subassembly 2, including the first and second anchors, can beloaded into a needle assembly 7 (also referred to as a front endreversed curve subassembly).

A tube pusher assembly 6 can be inserted proximally into a distal end ofa push button 3. A distal end of the tube pusher assembly 6 can beinserted into a distal end of the needle assembly 7. The tube pusherassembly 6 can be fed proximally through a bore of the needle assembly 7until the proximal end of the tube pusher assembly 6 is at or near aproximal end of the needle assembly 7.

A proximal end or proximal portion of the tube pusher assembly 6 can belocked to the push button 3 as follows. A wire lock 1 has a profile thatmatches a cut-out on the push button 3. The wire lock 1 can be insertedinto the cut-out on the push button 3, thereby pinching a proximal endof a wire of the tube pusher. The wire can be bent by ninety degrees atthe pinch point. An extra proximal portion of the wire, which can extendproximally beyond the pinch point, can be trimmed.

The wire lock can include a post that engages a distal end of a tensionspring 8 (also referred to as an extension spring). A proximal end ofthe tension spring 8 can be fed proximally through an interior of ahandle 5. The needle assembly 7 can include one or more outwardly-biasedwings near its proximal end. These wings plug into the handle 5. Ahandle lock 9 (also referred to as a front end lock) can be insertedinto a wall of the handle 5. Two prongs on the handle lock 9 can forcethe wings on the needle assembly 7 radially outward, and can prevent theneedle assembly 7 from being detached from the handle 5.

A back 4 (also referred to as a spring retainer) can include a post thatengages a proximal end of the handle 5, and, through the tension spring8, can lock the push button 3 and tube pusher assembly 6 to the handle5.

A piece of repair foam 11 can be packed with the repair device 100. Therepair foam 11 can be positioned distal to the push button 3, and canprevent the push button 3 from moving distally prior to use of therepair device 100. A surgeon removes the repair foam 11 just prior touse of the repair device 100.

An adjustable depth stop assembly 10 can set a depth for the needleassembly 7, corresponding to how deep the tube pusher assembly 6 canextend distally beyond a distal end of the needle assembly 7, when thepush button 3 is positioned at the proximal end of its range of travel,with respect to the handle 5. In some examples, the adjustable depthstop assembly 10 can include a window that blocks all but one labeledmark on the handle, so that as a surgeon adjusts the adjustable depthstop assembly 10, the surgeon can see a labeled mark corresponding tothe selected depth. The series of labeled marks can include numeralscorresponding to various depths.

In each of the configurations presented thus far, a pusher wire canextend through an interior of the anchors, and a tube pusher can extendover the pusher wire. In alternate configurations, the pusher wire canextend over the anchors (e.g., the pusher wire can have a hollowinterior and can extend around an exterior of the anchors). Such apusher wire can include teeth that extend inward and can engage anexterior of the anchors. For these alternate configurations, the tubepusher can be positioned inside the pusher wire and can engage aproximal end of the second anchor. In still other configurations, theproximal anchor can be positioned inside of a tube inside the needle,the tube can be advance to deploy the distal anchor, and a pusher insidethe inner tube can be advanced to deploy the proximal anchor. In stillother configurations, the pusher wire can route around an exterior ofthe anchors and engage the exterior of the anchors. For example, such apusher wire can engage anchors shapes as a flat braid sleeve, ratherthan cylindrical.

FIG. 12 shows a flow chart of an example of a method 1200 for deployingfirst and second anchors from a distal end of a bore of a needle, inaccordance with some embodiments. The method 1200 can be executed by arepair device 100 (FIG. 1), or another suitable repair device. Themethod 1200 is but one example for deploying first and second anchorsfrom a distal end of a bore of a needle; other suitable methods can alsobe used.

At operation 1202, the repair device can engage an interior of the firstanchor with teeth. The teeth can be positioned at a distal end of apusher wire.

At operation 1204, the repair device can advance the pusher wiredistally, with respect to the needle, to force the first anchor distallyout of the bore.

At operation 1206, the repair device can retract the pusher wireproximally, with respect to the needle and the second anchor, toposition the teeth inside an interior of the second anchor.

At operation 1208, the repair device can engage the interior of thesecond anchor with the teeth.

At operation 1210, the repair device can advance the pusher wiredistally, with respect to the needle, to force the second anchordistally out of the bore.

In some examples, the method 1200 can further include pushing the secondanchor distally from a first position within the bore to a secondposition within the bore. In some examples, the second anchor can bepushed distally at the same time that the first anchor is forceddistally out of the bore.

FIGS. 13-29 show views of various stages of a specific example of how asurgeon can use a meniscal repair device, such as 100 (FIG. 1). This isbut one example of a surgical repair procedure; other suitable examplescan also be used.

First, the surgeon can perform a diagnostic arthroscopy. During thediagnostic arthroscopy, the surgeon can assess a location of themeniscal tear and determine the reparability of the lesion. The surgeoncan determine an optimum medial portal placement using an 18-gaugespinal needle and direct arthroscopic visualization to create a medialworking portal. The surgeon can position the needle to enter just abovethe anterior medial meniscus parallel to the tibial joint surface (FIG.13). The surgeon can avoid placing the portal too superior or inferiorand can ensure that the medial portal is large enough to readily pass aninserter and a suture cutter. The surgeon can measure a distance from aback side of the meniscus to a desired needle penetration point at therepair site using a meniscal depth gauge.

Next, the surgeon can decide on a suitable approach, choosing between astraight needle option and curved needle option and selecting a suitableportal. Meniscal repair devices are typically produced with one of twoneedle shapes, namely straight and curved. The surgeon can utilize aprobe through the medial portal to help determine whether a straight orcurved needle will position the implant optimally. Selecting between astraight or curved needle can depend on the location of the tear, and onthe location of the portal (e.g., the location of the skin incision). Itcan be preferable to choose a needle shape so that the needle emergesthrough the back of the tissue and not the underside of the tissue. Formost meniscal repairs, the surgeon can often select the curved needleoption. The surgeon can approach posterior horn tears from the medialportal (FIG. 14A), including both medial and lateral tears. The surgeoncan approach the mid-body tears from a contralateral portal (FIG. 14B).To adjust a needle depth, if needed, the surgeon can push down on adepth control slider in a forward motion to decrease the needle lengthexposed (FIG. 15).

Next, the surgeon can position the meniscal repair device. The surgeoncan advance the half pipe cannula sled through the selected portal tothe meniscus. The surgeon can slide a sharp point against a half pipecannula sled to advance the meniscal repair device into the joint.Advancing in this manner can limit catching the device on soft tissue.The surgeon can retract the half pipe cannula sled from the joint spaceonce the meniscal repair device has been successfully inserted into thejoint space (FIG. 16). Using the curved needle, the surgeon can enterthe superior surface of the meniscus with the tip of the needle pointedinferiorly (FIG. 17). After the needle tip penetrates the meniscus, thesurgeon can rotate the inserter 180 degrees (about a longitudinal axisof the meniscal repair device). The surgeon can then advance the needlejust beyond the meniscocapsular junction (FIG. 18). This technique canhelp the meniscal implant pass completely through the meniscal tissueand the meniscocapsular junction.

Next, the surgeon can deploy the first anchor. Once the meniscal repairdevice is inserted at the repair site, the surgeon can advance the pushbutton forward to deploy the first anchor (e.g., push the first anchorout of the meniscal repair device) (FIG. 19). The meniscal repair devicecan emit an audible click to indicate that the implant has fullyadvanced through the meniscus (FIGS. 20A-C). The meniscal repair devicecan advance the second anchor forward, and place the needle in thelocation previously occupied by the first anchor. The surgeon can fullyretract the push button and pull the needle tip gently out of themeniscus (FIG. 21).

Next, the surgeon can deploy the second anchor. The surgeon canreposition the needle tip at a desired location and can advance thecurved needle tip as described above (FIG. 22). The surgeon can advancethe needle beyond the meniscocapsular junction. The surgeon can advancethe push button forward to deploy the second anchor (e.g., push thesecond anchor out of the meniscal repair device) (FIG. 23). The surgeoncan fully retract the push button and can completely remove the meniscalinserter from the joint (FIG. 24).

The surgeon can choose to position the anchors in a suitable patternthat is matched to the particular tear of the meniscus. In someexamples, the surgeon can position one anchor above the other, in aso-called horizontal mattress pattern. In other examples, the surgeoncan position the anchors side by side, in a so-called vertical mattresspattern. The vertical mattress stitching pattern can be well-suited formeniscal repairs due to its ability to achieve deep and superficialwound closure, edge eversion and precise vertical alignment of thesuperficial wound margins. The surgeon can insert the first anchor onthe inferior meniscal rim. The surgeon can insert the second anchorsuperior to the tear on the meniscal rim. Implants in this superiormeniscal location can require shorter distances of deployment, since thedepth of meniscus can be less than the depth at the inferior location(FIG. 25). To decrease the needle depth for the superior position, thesurgeon can adjust an adjustable depth stop until the needle reaches adesired depth (FIG. 26).

Next, the surgeon can tension the suture. After the surgeon retracts themeniscal repair device from the joint, a suture loop and a single strandcan protrude from the portal. The suture loop and single strand can beformed from a single piece of suture run through itself, and configuredas an adjustable loop. If the surgeon pulls on the loop, the loop doesnot increase in size. If the surgeon pulls on the single strand, theloop shrinks. Deploying the anchors as described above can produce asmall loop of suture inside the joint, a larger loop of suture emergingfrom the skin, and a free strand emerging from the skin. The surgeon canuse index and middle fingers to pull on the larger loop (in some cases,a blue/white side of the loop) with multiple short tugs to set theanchors at the repair site (FIG. 27A). The surgeon can pull on one sidethe larger loop until the surgeon is satisfied with the tension on thesmaller loop. Advantageously, the suture loop can include segmentshaving different colors or different patterns, which, when the anchorsare deployed, can visually indicate which side of the loop the surgeonshould pull to set the loop tension. In a specific example, the segmentto be pulled includes a blue suture with a white tracer, while thesegment that should not be pulled is all white. In some examples, whenthe blue/white portion of the suture loop no longer moves in response tothe tugs, the anchor is fully set. The surgeon can visually confirm,with a scope, that the anchor is fully set at the repair site (FIG.27B). The surgeon can pull the single strand (in some cases, coloredwhite) to contract the large loop down to the surface of the meniscus.The surgeon can pull on the strand until tension on the second loopmatches the tension of the first loop (FIG. 28). If desired, the surgeoncan use a probe to check the repair site for appropriate tension.

Finally, the surgeon can cut the suture. The surgeon can insert a cutterinto the portal and advance the cutter to sever the suture, therebycompleting fixation and repair of the meniscus (FIG. 29).

The meniscal repair device discussed in detail above improves overcomparable meniscal repair devices. For example, the present meniscalrepair device uses an anchor formed from a suture sleeve, which ispreferable to using a hard plastic anchor, made from a relatively hardmaterial, such as polyether ether ketone (PEEK). In cases where thesuture pulls through the meniscal tissue, the anchor could be dislodgedwithin the knee joint space. A hard plastic anchor could cause jointdamage by moving within the joint space. The all-suture anchor of thepresent meniscal repair device would not cause such damage. As anotheradvantage, the present meniscal repair device uses two suture strandsacross the tissue, rather than a single suture strand, which candistribute the suture force over a larger tissue area and thereforereduce the likelihood that suture will rip through the tissue. As stillanother advantage, the present can deploy the anchors without using anypre-tied suture knots, which in some cases could rub against the femurand potentially damage the femur.

To further illustrate the device and related method disclosed herein, anon-limiting list of examples is provided below. Each of the followingnon-limiting examples can stand on its own, or can be combined in anypermutation or combination with any one or more of the other examples.

In Example 1, a repair device comprises: a needle defining a boreextending through a distal end of the needle; a cylindrical first anchorsized and shaped to be disposed in the bore proximal to a distal end ofthe bore; a cylindrical second anchor sized and shaped to be disposed inthe bore proximal to the first anchor; and a pusher wire including teethpositioned at a distal end of the pusher wire, the teeth configured to:engage an interior of the first anchor; advance distally, with respectto the needle, to force the first anchor distally out of the bore;retract proximally, with respect to the needle and the second anchor, toposition the teeth inside an interior of the second anchor; engage theinterior of the second anchor; and advance distally, with respect to theneedle, to force the second anchor distally out of the bore.

In Example 2, the device of Example 1 can optionally be configured suchthat the teeth are sized and shaped to: catch and engage on theinteriors of the first and second anchors when the pusher wire and teethare advanced distally with respect to the first and second anchors,respectively; and slide along the interiors of the first and secondanchors non-damagingly when the pusher wire and teeth are retractedproximally with respect to the first and second anchors, respectively.

In Example 3, the device of any one or a combination of Examples 1-2 canoptionally be configured such that the pusher wire has an outer diametersmaller than respective inner diameters of the first and second anchors,so that the pusher wire is non-engagingly slidable through the first andsecond anchors in the proximal and distal directions.

In Example 4, the device of any one or a combination of Examples 1-3 canoptionally be configured to further comprise a tube pusher positionedover the pusher wire within the bore of the needle, the tube pusherhaving a distal portion that extends radially beyond an outercircumference of the second anchor, so that the tube pusher pushes thesecond anchor distally as the tube pusher advances distally within thebore of the needle.

In Example 5, the device of any one or a combination of Examples 1-4 canoptionally be configured to further comprise a handle fixedly coupled toa proximal end of the needle; and a push button disposed on an exteriorof the handle, the push button being slidable proximally and distallywith respect to the handle between a first proximal position and a firstdistal position, the push button being coupled to the pusher wire sothat proximal and distal movement of the push button produces proximaland distal movement of the pusher wire and teeth.

In Example 6, the device of any one or a combination of Examples 1-5 canoptionally be configured such that the push button is slidable to thefirst distal position on the handle; and further comprising anadjustable depth stop assembly configured so that movement of the pushbutton to the first distal position distally advances the teeth to aselectable distance beyond a distal end of the needle.

In Example 7, the device of any one or a combination of Examples 1-6 canoptionally be configured such that the handle is configured to emit anaudible click when the push button reaches the first distal position onthe handle.

In Example 8, the device of any one or a combination of Examples 1-7 canoptionally be configured such that the push button is slidable to afirst proximal position on the handle; and the teeth are positionedwithin the first or second anchors when the push button is positioned atthe first proximal position.

In Example 9, the device of any one or a combination of Examples 1-8 canoptionally be configured such that the handle is configured to emit anaudible click when the push button reaches the first proximal positionon the handle.

In Example 10, the device of any one or a combination of Examples 1-9can optionally be configured such that proximal motion of the pushbutton does not move the tube pusher proximally.

In Example 11, the device of any one or a combination of Examples 1-10can optionally be configured such that distal motion of the push buttonadvances the tube pusher distally.

In Example 12, the device of any one or a combination of Examples 1-11can optionally be configured such that the teeth are positioned withinthe first anchor when the push button is positioned at the firstproximal position; the push button is slidable to a second proximalposition on the handle; and the teeth are positioned within the secondanchor when the push button is positioned at the second proximalposition.

In Example 13, the device of any one or a combination of Examples 1-12can optionally be configured such that the handle is configured to emitan audible click when the push button reaches the second proximalposition on the handle.

In Example 14, the device of any one or a combination of Examples 1-13can optionally be configured such that proximal or distal motion of thepush button does not move the tube pusher proximally or distally.

In Example 15, the device of any one or a combination of Examples 1-14can optionally be configured such that the first and second anchors areconnected by an adjustable suture loop.

In Example 16, a method for deploying first and second anchors from adistal end of a bore of a needle can comprise: engaging an interior ofthe first anchor with teeth, the teeth being positioned at a distal endof a pusher wire; advancing the pusher wire distally, with respect tothe needle, to force the first anchor distally out of the bore;retracting the pusher wire proximally, with respect to the needle andthe second anchor, to position the teeth inside an interior of thesecond anchor; engaging the interior of the second anchor with theteeth; and advancing the pusher wire distally, with respect to theneedle, to force the second anchor distally out of the bore.

In Example 17, the method of Example 16 can optionally further comprise:pushing the second anchor distally from a first position within the boreto a second position within the bore.

In Example 18, the method of any one or a combination of Examples 16-17can optionally be configured such that the second anchor is pusheddistally at the same time that the first anchor is forced distally outof the bore.

In Example 19, a repair device can comprise: a needle defining a boreextending through a distal end of the needle; a cylindrical first anchordisposed in the bore proximal to a distal end of the bore; a cylindricalsecond anchor disposed in the bore proximal to the first anchor andconnected to the cylindrical first anchor by an adjustable suture loop;a pusher wire having an outer diameter smaller than respective innerdiameters of the first and second anchors, so that the pusher wire isnon-engagingly slidable through the first and second anchors in theproximal and distal directions, the pusher wire including teethpositioned at a distal end of the pusher wire, the teeth being sized andshaped to: catch and engage on interiors of the first and second anchorswhen the pusher wire and teeth are advanced distally with respect to thefirst and second anchors, respectively; and slide along the interiors ofthe first and second anchors non-damagingly when the pusher wire andteeth are retracted proximally with respect to the first and secondanchors, respectively; a tube pusher positioned over the pusher wirewithin the bore of the needle, the tube pusher having a distal portionthat extends radially beyond an outer circumference of the secondanchor, so that the tube pusher pushes the second anchor distally as thetube pusher advances distally within the bore of the needle; a handlefixedly coupled to a proximal end of the needle; and a push buttondisposed on an exterior of the handle, the push button being slidableproximally and distally with respect to the handle between a firstproximal position and a first distal position, the push button beingcoupled to the pusher wire so that proximal and distal movement of thepush button produces proximal and distal movement of the pusher wire andteeth.

In Example 20, the device of Example 19 can optionally be configuredsuch that the push button is slidable to the first distal position onthe handle; wherein the handle is configured to emit an audible clickwhen the push button reaches the first distal position on the handle;and further comprising an adjustable depth stop assembly configured sothat movement of the push button to the first distal position distallyadvances the teeth to a selectable distance beyond a distal end of theneedle.

While this invention has been described as having example designs, thepresent invention can be further modified within the spirit and scope ofthis disclosure. This application is therefore intended to cover anyvariations, uses, or adaptations of the invention using its generalprinciples. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this invention pertains and which fallwithin the limits of the appended claims.

1.-20. (canceled)
 21. A method of meniscal repair, comprising: (i)advancing an open distal end of a needle through a tear in a meniscus toa first location, wherein the needle comprises a longitudinal bore thatextends through the needle to the open distal end, and wherein, duringstep (i), a deformable first anchor and a deformable second anchor arepositioned in the longitudinal bore of the needle with the deformablesecond anchor located proximal of the deformable first anchor in thelongitudinal bore and with a pusher wire extending in the longitudinalbore from a proximal end of the needle, past the deformable secondanchor by routing the pusher wire around an exterior of the deformablesecond anchor, and into engagement with the deformable first anchor, thepusher wire including at least a first tooth that projects from a sideof the pusher wire; (ii) moving the pusher wire distally in thelongitudinal bore of the needle following step (i) to thereby force thedeformable first anchor out of the longitudinal bore through the opendistal end of the needle via engagement of the pusher wire with thedeformable first anchor, wherein, during step (ii), the pusher wireremains extending past the deformable second anchor in the longitudinalbore of the needle; (iii) moving the pusher wire proximally in thelongitudinal bore of the needle following step (ii) to thereby retractthe first tooth in the longitudinal bore of the needle, wherein, duringstep (iii), the first tooth moves proximally past at least part of thedeformable second anchor in the longitudinal bore by routing the firsttooth around the exterior of the deformable second anchor in thelongitudinal bore; (iv) withdrawing the open distal end of the needleback through the tear in the meniscus following step (ii); (v) advancingthe open distal end of the needle through the tear in the meniscus to asecond location following step (iv); (vi) moving the pusher wiredistally in the longitudinal bore of the needle following step (v) tothereby force the deformable second anchor out of the longitudinal borethrough the open distal end of the needle via engagement of the pusherwire with the deformable second anchor.
 22. The method of claim 21,wherein, during step (iii), a tube pusher is received in thelongitudinal bore of the needle over the pusher wire with a distal endof the tube pusher contacting the deformable second anchor to provide astop for the deformable second anchor.
 23. The method of claim 21,wherein the deformable first anchor is coupled to the deformable secondanchor with a suture.
 24. The method of claim 23, wherein the suturecomprises an adjustable knotless loop.
 25. The method of claim 24further comprising pulling on a free end of the suture following step(vi) to reduce a size of the adjustable knotless loop and thereby reducethe tear in the meniscus.
 26. The method of claim 21, wherein at leastone of the deformable first anchor and the deformable second anchorcomprises a braided material.
 27. The method of claim 26, wherein atleast one of the deformable first anchor and the deformable secondanchor comprises a flat braided material.
 28. The method of claim 21,wherein at least one of the deformable first anchor and the deformablesecond anchor comprises a hollow cylindrical anchor.
 29. The method ofclaim 21, wherein the pusher wire includes a second tooth.
 30. A methodof tissue repair, comprising: (i) passing an open distal end of a needleinto a body of a patient, wherein the needle comprises a longitudinalbore that extends through the needle to the open distal end, andwherein, during step (i), a deformable first anchor and a deformablesecond anchor are positioned in the longitudinal bore of the needle withthe deformable second anchor located proximal of the deformable firstanchor in the longitudinal bore and with a pusher wire extending in thelongitudinal bore from a proximal end of the needle, past the deformablesecond anchor by routing the pusher wire around an exterior of thedeformable second anchor, and into engagement with the deformable firstanchor, the pusher wire including at least a first tooth that projectsfrom a side of the pusher wire; (ii) moving the pusher wire distally inthe longitudinal bore of the needle following step (i) to thereby forcethe deformable first anchor out of the longitudinal bore through theopen distal end of the needle via engagement of the pusher wire with thedeformable first anchor, wherein, during step (ii), the pusher wireremains extending past the deformable second anchor in the longitudinalbore of the needle; (iii) moving the pusher wire proximally in thelongitudinal bore of the needle following step (ii) to thereby retractthe first tooth in the longitudinal bore of the needle, wherein, duringstep (iii), the first tooth moves proximally past at least part of thedeformable second anchor in the longitudinal bore by routing the firsttooth around the exterior of the deformable second anchor in thelongitudinal bore; and (iv) moving the pusher wire distally in thelongitudinal bore of the needle following step (iii) to thereby forcethe deformable second anchor out of the longitudinal bore through theopen distal end of the needle via engagement of the pusher wire with thedeformable second anchor.
 31. The method of claim 30, wherein, duringstep (iii), a tube pusher is received in the longitudinal bore of theneedle over the pusher wire with a distal end of the tube pushercontacting the deformable second anchor to provide a stop for thedeformable second anchor.
 32. The method of claim 30, wherein steps(ii)-(iv) comprises moving a push button connected to the pusher wire.33. The method of claim 30, wherein the deformable first anchor iscoupled to the deformable second anchor with a suture.
 34. The method ofclaim 33, wherein the suture comprises an adjustable knotless loop. 35.The method of claim 34 further comprising pulling on a free end of thesuture following step (iv) to reduce a size of the adjustable knotlessloop.
 36. The method of claim 30, wherein at least one of the deformablefirst anchor and the deformable second anchor comprises a braidedmaterial.
 37. The method of claim 36, wherein at least one of thedeformable first anchor and the deformable second anchor comprises aflat braided material.
 38. The method of claim 30, wherein at least oneof the deformable first anchor and the deformable second anchorcomprises a hollow cylindrical anchor.
 39. The method of claim 30,wherein step (i) comprises advancing the open distal end of the needlethrough a tear in a meniscus of the patient.
 40. The method of claim 30,wherein the pusher wire includes a second tooth.